Fresh tur­moil in­side No­var­tis’ re­vamped CAR-T or­ga­ni­za­tion as top ex­ec jumps ship

There’s more tur­moil to re­port from in­side No­var­tis’ CAR-T camp.

On Fri­day Karen Walk­er will leave a se­nior po­si­tion in charge of CMC/man­u­fac­tur­ing of CAR-Ts for No­var­tis in ex­change for a new po­si­tion she’s tak­ing at Seat­tle Ge­net­ics, End­points News has learned.

Walk­er — the VP Glob­al Head Cell and Gene Ther­a­pies Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing at No­var­tis — was one of three se­nior ex­ecs put in charge of the cell and gene ther­a­py ini­tia­tive at the com­pa­ny last fall, ac­cord­ing to sources close to the com­pa­ny, af­ter a bruis­ing re­struc­tur­ing over the sum­mer in which the unit was chopped up and ab­sorbed in­side a huge R&D or­ga­ni­za­tion. Samuele Butera was put in charge of the com­mer­cial/busi­ness as­pect of the group while David Leb­wohl han­dles clin­i­cal ops.

“Karen Walk­er will join Seat­tle Ge­net­ics as Vice Pres­i­dent of Glob­al Qual­i­ty in mid-April,” con­firmed a spokesper­son for Seat­tle Ge­net­ics.

I con­tact­ed Er­ic Al­thoff, a spokesper­son for No­var­tis, Wednes­day night, but af­ter ac­knowl­edg­ing my query he did not fol­low up. Al­thoff has de­clined to re­spond to a fol­lowup query.

No­var­tis has been bleed­ing tal­ent through­out its glob­al or­ga­ni­za­tion for the past year. Walk­er’s de­par­ture, though, comes at a par­tic­u­lar­ly crit­i­cal stage for No­var­tis, just days af­ter the phar­ma gi­ant gained a pri­or­i­ty re­view for CTL019, putting it on a short path to per­haps the first his­toric ap­proval for a CAR-T.

Last sum­mer End­points broke the sto­ry about No­var­tis’ re­or­ga­ni­za­tion in CAR-T, which led the group’s top ex­ec, Us­man ‘Oz’ Azam, to leave No­var­tis. About 120 staffers were al­so ter­mi­nat­ed as the sep­a­rate group was pulled back in­to the R&D struc­ture.

No­var­tis has kept up a neck-and-neck race with Kite on the lead pro­gram, which has its own pi­o­neer­ing CAR-T head­ed to the FDA.

Man­u­fac­tur­ing in this field is crit­i­cal. To make this ther­a­py, physi­cians ex­tracts cells from can­cer pa­tients and then reengi­neer them with a chimeric anti­gen re­cep­tor to guide them to at­tack can­cer cells. The re­vised cells are then in­ject­ed back in­to pa­tients. To be com­pet­i­tive, a com­pa­ny has to prove not on­ly that they know how to make the ther­a­py, they al­so have to be able to turn it around quick­ly for use.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.